Previously, I examined the best ways to overcome challenges with a new pharmacovigilance system. I now want to provide a hypothetical example of reactive pharmacovigilance.
Company A launches a first-in-class drug/device combo biologic for the treatment of psoriatic arthritis. The drug has a novel mechanism of action. In clinical trials, the American College of Rheumatology response was 26 weeks. The drug is dispensed as a self-injectable to the patient after the patient has undergone the proper screening and education for self-administration.
The launch of the drug is complicated by the lack of support from payers and providers due to the cost of the medication, even though the clinical trial data overwhelmingly shows that in the majority of patients, symptoms of disease and long-term sequelae are delayed. The payers and providers are concerned that the high cost of the drug and its benefit will be offset by a lack of patient compliance. Once-weekly dosing has been shown to be a compliance challenge and compounding this particular therapy is the ability of the patient to self-inject.
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The early post-marketing period showed that a lack of drug effect was the most-common AE reported (16-20 weeks post-launch) with more than 90% of all AEs reporting no change in clinical symptoms or resolution of plaque size and number. Post-marketing data at 36 weeks showed 86% of all AEs were lack of effect and disease progression despite Company A ruling out product quality issues.
Company A continued to monitor the lack of effect and at 52 weeks post-launch, 38% of patients who had begun therapy at launch had discontinued the product. Notable AEs were not different from those observed in clinical trials other than a higher percentage of patients who complained of difficulty in the administration of the drug with the device, stinging/localized irritation at the site of injection, and the continued high reporting of lack of effect. PQC investigations using retain samples did not show any differences in pH, rate of product administration or other interactions between the product and the delivery device (i.e., no secondary issues with drug/vehicle contact with syringe/needle and storage method.
Company A is notified by the regulatory authority to engage in discussions regarding the risk/benefit of the product, and there is no positive movement for payer providers to cover the cost of the promising drug from its clinical trial experience and early post-marketing experience.
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